EU prepares to re-open REACH 'can of worms'

Five years after its adoption, the European Commission is preparing to review the controversial REACH regulation, which for the first time required chemical manufacturers to justify that their products are safe for consumers. It's a potential "can of worms," according to EU officials.

From the moment it was tabled until its eventual adoption in 2006, the REACH regulation gave rise to one of the most epic lobbying battles in the EU's history, pitting green campaigners against the powerful chemicals industry.

Five years on, the European Commission is preparing to review the controversial piece of legislation, which sought to protect consumers' health and the environment from the dangerous effects of toxic chemicals.

"I think it is a start and a very important start," said Jamie Page from the Cancer Prevention and Education Society, a non-profit group that supports REACH's objectives.

Adopted in 2006, REACH sought to review the 100,000-odd chemical substances which are currently on the market and screen them for potential threats to human health or the environment.

Since then, only a small number of chemicals have actually been reviewed, starting with a list of 47 Substances of Very High Concern (SVHC), which are suspected of causing cancer or disturbing the human reproductive system.

But there are a lot more substances out there, said Page, who is calling for the screening process to be accelerated. "Obviously, there are a lot of chemicals on the market – people estimate between 80,000 and 100,000 – so it is like a few down, a lot to go."

"There are a lot of controversial products," Page concurred, citing Bisphenol A, a compound which has recently been banned in plastic baby bottles but which some scientists believe could be harmful in other guises, such as coatings for food cans.

Some dangerous chemicals have been removed from the market, said Page, but "there is an issue of whether those [substances] can be evaluated properly," he added, pointing out that a full ban on Bisphenol A was still being discussed at EU level.

"The methodologies which are being used to justify that they are kept on the market – we would like to see more transparency on that."

Confidentiality matters

Within the chemicals industry, efforts have focused on complying with the complex EU regulation while protecting legitimate business interests. Companies that want to sell chemicals must register them with the European Chemicals Agency (ECHA) in Helsinki, including details on toxicity, which the agency publishes on its website.

One contentious issue is whether ECHA should make all the toxicity data available to the public or whether parts of it should remain confidential to protect company's patents.

Cefic, which represents European chemicals firms, complained recently that publishing company names against toxicity data sheets might give overseas rivals an insight into their innovation strategies.

Anti-toxics campaigners have countered that such information is crucial to hold companies to account over the safety of their products.

The REACH review, due in 2012, will assess whether changes here are necessary.

Unintended consequences

Others have criticised the law for targeting the wrong substances. The REACH regulation was initially designed to protect consumers from exposure to hazardous chemicals, but the bureaucracy it created ended up encompassing metals such as cobalt, which hardly comes into contact with consumers at all.

David Weight, from the Cobalt Development Institute, an organisation representing major producers of the metal, said REACH had "very laudable ambitions" but criticised it for its unintended consequences.

"Where we have misgivings is in the implementation," Weight explained, saying that there is "no consumer exposure" to cobalt and that it is therefore "not really the sort of substance that should fall under the spotlight".

"This is where we should have much closer discussion," Weight said, referring to the opportunities that a review would offer to fine-tune the legislation.

"At the end of the day, the changes for health and for the environment will be imperceptible," Weight argued, referring to a possible restriction on cobalt. Meanwhile, the heavy bureaucratic burden imposed by REACH "may well have damaged the economy," he warned, saying the regulation had introduced new trade barriers for cobalt.

Andrew Miller, a Labour MP who chairs the science and technology committee in the UK parliament, agreed. He said policymakers should adopt different approaches for substances that aren't dangerous and those "that are known to be harmful to human health".

In June, the committee produced a report, which said REACH had introduced "de facto import tariffs" on some strategic raw materials by requesting importers to submit registration dossiers for all kinds of substances.

Anthony Lipmann, of Lipmann Walton & Co Ltd., a small company importing various strategic metals, told the committee that he had to spend "a lot of money" to register products with the European Chemicals Agency (ECHA).

In one instance, Lipmann said his company had to purchase a letter of access (LOA) to import 1,000 tonnes of titanium, which cost him €40,000. Although he only needed to import 100 tonnes of titanium, he still had to pay €40,000.

"If you translate that across the 20 elements that I trade, it is untenable," he told the committee.

'Be careful what you wish for'

A senior EU official dealing with REACH seemed to agree with critics, saying the value of the regulation lies in making sure that only hazardous substances are screened, not those that pose no health or environmental threat.

But he also played down expectations, saying the review would be fairly limited in scope. Speaking on condition of anonymity, the official cautioned that a full-blown revision could open up "a can of worms".

"Be careful what you wish for," warned the official, who was speaking at a stakeholder workshop organised by EurActiv in London last June.

The Commission review will be based on a report drawing on lessons learned from the implementation of REACH, "with special attention to the costs and administrative burden and other impacts on innovation". This will include a review of registration requirements for lower tonnage substances.

Other aspects of the review will include:

A review of the amount and distribution of funding made available by the Commission for the development and evaluation of alternative test methods (Art. 117.4 of REACH).

Whether or not to amend the scope of REACH in order to avoid overlaps with other EU legislation (Art. 138.6).

A review of the European Chemicals Agency (Art. 75.2).

Frédéric Simon

Background

Adopted in 2006, the REACH regulation requests industry to register the 100,000 or so substances which are currently on the market and submit them for safety screening and subsequent authorisation (see our LinksDossier).

As part of the process, EU member states have proposed a number of chemicals for inclusion on a list of Substances of Very High Concern (SVHC), which should be screened as a priority. These include substances that cause cancer, birth defects or which accumulate in human bodies and in the environment.

The European Chemicals Agency (ECHA) published the first candidate list of 15 chemicals that present the most cause for concern in October 2008. The list has since been updated and now includes 47 substances.

Positions

In June, Fondation EurActiv organised a stakeholder workshop in London to take stock of the REACH regulation five years after its adoption. EUX.tv provides a video summary of key stakeholders' views below:

Timeline

By 1 June 2012: European Commission to launch REACH review with a series of reports examining how the regulation has worked so far.

It may decide to table a legislative proposal to amend REACH at a later stage.

Related Content

The European Food Safety Authority (EFSA) seems confident that research on the toxicity of low doses of chemicals in food is irrelevant to risk assessment. This is despite mounting evidence that low-dose exposure, particularly to endocrine-disrupting chemicals, could be contributing to rising rates of a number of diseases, writes Paul Whaley.

The Czech and Slovak governments are pressuring European leaders to reconsider “excessive” safety regulations on the chemicals industry that they contend hurt smaller businesses and undermine economic growth.

Shanna H. Swan, a renowned scientist specialising in reproductive medicine, has warned about the health effects of endocrine disrupting chemicals (EDCs) such as phthalates which can end up in food via pesticides or plastics. In an interview with EurActiv, she calls on regulators to better protect consumers against those "hidden chemicals".

The European Parliament, in agreement with EU member states, has added 12 new substances to the EU priority list of pollutants known to pose a risk to surface water. For the first time, three pharmaceuticals will also be included on a "watch list" of emerging pollutants that could one day be added to the priority list.

Danish Environment Minister Ida Auken has decided to ban four industrial chemicals linked to disrupting the human endocrine system, pushing Denmark ahead of the European Union which has already started a process of phasing out phthalates.

BASF, the German chemical giant, has distanced itself from the rest of the industry by saying Europe's REACH chemical safety law was worth the investment in the end. A review of the legislation is expected this month.

Two years after toxic sludge from an aluminium plant burst through a dam in western Hungary, a top United Nations representative is due to visit the area to investigate the human rights and environmental impact of the deadly incident.

Current legislative work on endocrine disruptors, which is potentially being undermined by the Transatlantic Trade and Investment Partnership (TTIP), is a prime example of how short term profits are being given priority over people and the environment, argues Robert Pederson.

The European Commission’s drive to simplify legislation for businesses – the Better Regulation Agenda – has come under fire from trade unions for blocking EU laws that could save thousands of lives per year.

The EU must take action to reduce human's exposure to suspected hormone-affecting endocrine disruptors. Current regulation should be closely examined with a view to updating or proposing new legislation by June 2015 at the latest, the European Parliament's Public Health Committee said in resolution approved yesterday (23 January).